FDA recall Z-1675-2023

Elekta, Inc. · Class II · device

Product

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Reason for recall

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Distribution

US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.

Key facts

Status
Ongoing
Initiation date
2023-04-06
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1675-2023